As featured in Manufacturing Chemist publication 30th Mar 2021.
The companies are developing a version of BB-NCIPD’s Td vaccine using Stablepharma’s StablevaX technology
Stablepharma has announced a collaboration with European vaccine manufacturer BB-NCIPD (Bul Bio), to develop a thermally stable version of the Tetanus diphtheria (Td) vaccine using the patented StablevaX formulation and device.
“We have established a strategic R&D partnership, alongside a statement of Intention for the future development and commercialisation of the StablevaX Td product – this is an excellent and exciting opportunity for both parties,” said Stablepharma’s MD and co-founder, Nick Child.
BB-NCIPD, founded in 1881, supplied ~9% of the global demand for Td vaccines in 2019 according to WHO data. The global demand for the vaccine is estimated to be around 270 million doses, and continues to grow mainly driven by WHO’s recommendation in 2015 of moving from Tetanus alone to the Td combination vaccine. WHO projects the demand to grow to 410 million doses by 2030.
“This is a timely and opportune moment to partner and progress this R&D programme with an innovative vaccine stabilisation company. We look forward to working with the team at Stablepharma” said Dr Roumen Kofinov, General Manager of BB-NCIPD.
As part of the supply agreement, Bul Bio will provide Stablepharma with its bulk Tetadif vaccine which will be converted to the StablevaX formulation to produce a thermally stable version.
“We have developed a positive working relationship with BB-NCIPD Ltd over the last year and have been working on signing an R&D and commercialisation deal with BB-NCIPD Ltd, so we are very pleased. Tetanus & Diphtheria containing vaccines market is expected to reach $7 bn by 2027 and Bul Bio is one of the five WHO PQ’ed suppliers of the Td vaccine globally. Our aim is to produce the world’s first fridge free Td vaccine,” said Stablepharma’s Board Director and Head of Strategy, Ozgur Tuncer.
Stablepharma have already shipped the first batch of StablevaX products with BB-NCIPD, starting the in-vivo challenge trials this week. A series of trials, all conducted to WHO protocols, will be run with further batches that have been stored at 45 °C, due to be shipped later this month. The aim is to prove a thermally stable StablevaX version of the Td vaccine will be as effective as the standard fresh vaccine.
Stablepharma was awarded an Innovate UK grant in November 2020, which will be used to finance GMP preclinical trials for the StablevaX Td vaccine. The award will help progress Stablepharma and BB-NCIPD’s Td programme forward to human clinical trials.
The animal challenge trial data produced by BB-NCIPD will be invaluable, the companies say, as Stablepharma move forward with the first in human clinical trials, the company will be looking to develop other stable vaccines from a ‘candidate list’ of over 60 approved vaccines that now potentially includes some of the COVID-19 vaccines.
Child said: “The StablevaX invention is the culmination of decades of work by Stablepharma founder Dr Bruce Roser, who focused on the preservation of perishable vaccines, that require constant & precise refrigeration from the factory to the patient, be it in a UK Hospital or a clinic in Africa. The WHO estimates that c 50% of all vaccines are wasted, if we can help to solve that problem, we can alleviate significant suffering and save many lives, this would be a tremendous outcome for all of us’’.